Apparatuses and methods for extracting chemicals from bodily cavities and breath

ABSTRACT

A chemical extraction apparatus has absorbent material for absorbing or adsorbing volatile chemicals from a breath of a user. The chemical extraction apparatus is positioned within such that breaths from the user flow over the absorbent material thereby causing volatile chemicals in the breaths to absorb or adsorb into the absorbent material. The absorbent material is then analyzed to determine the amount of chemicals absorbed or adsorbed into the absorbent material. Based on such analysis, various diseases or conditions can be detected or diagnosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 15/280,395, entitled “Apparatuses and Methods forExtracting Chemicals from Bodily Cavities and Breath,” and filed on Sep.29, 2016. U.S. patent application Ser. No. 15/280,395 is a continuationof and claims priority to U.S. patent application Ser. No. 12/772,016,entitled “Methods for Extracting Chemicals from Nasal Cavities andBreath,” and filed on Apr. 30, 2010. U.S. patent application Ser. No.12/772,016 claims priority to U.S. patent application Ser. No.12/401,051, entitled “Apparatuses and Methods for Extracting Chemicalsfrom the Oral Cavity and Breath,” and filed on Mar. 10, 2009, which isincorporated herein by reference. U.S. patent application Ser. No.12/772,016 claims priority to U.S. Provisional Patent Application No.61/174,327, entitled “Apparatuses and Methods for Extracting Chemicalsfrom the Oral Cavity and Breath,” and filed on Apr. 30, 2009, which isincorporated herein by reference. U.S. patent application Ser. No.12/401,051 claims priority to U.S. Provisional Patent Application No.61/035,266, entitled “Method and Apparatus for Extracting Volatile andSemi-Volatile Compounds from the Oral Cavity and Breath,” and filed onMar. 10, 2008, which is incorporated herein by reference. U.S. patentapplication Ser. No. 12/401,051 also claims priority to U.S. ProvisionalPatent Application No. 61/036,673, entitled “Chewing Device forExtracting Volatile and Semi-Volatile Compounds from the Oral Cavity andBreath, and Method for Making Same,” and filed on Mar. 14, 2008, whichis incorporated herein by reference. U.S. patent application Ser. No.12/401,051 claims priority to U.S. Provisional Patent Application No.61/036,646, entitled “Method and Apparatus for Extracting Volatile,Semi-Volatile Compounds from the Oral Cavity and Breath,” and filed onMar. 14, 2008, which is incorporated herein by reference. U.S. patentapplication Ser. No. 12/401,051 claims priority to U.S. ProvisionalPatent Application No. 61/148,297, entitled “Apparatuses and Methods forExtracting Chemicals from the Oral Cavity and Breath,” and filed on Jan.29, 2009, which is incorporated herein by reference.

RELATED ART

Advances in instrumentation have resulted in new generations ofreliable, accurate, and precise tools for the scientist (analyticalchemist, food scientist, biochemist, biologist). Technical advances haveopened new areas for research including the field of metabolomics, thestudy of metabolites produced in the body related to disease.Metabolomics is a rapidly growing research field and promises to makedisease detection and diagnosis less invasive and much more rapid.Difficult and time consuming procedures that currently require blood,stool, urine, or even more invasive tissue collection samples will berequired much less frequently, or not at all. Sources of metabolitesinclude blood, urine, feces, sweat, and breath. Breath analysis ischallenging because compounds present are smaller (lower molecularweight, typically less than 300 g/mole), volatile (exist preferentiallyin the gas state), and reactive. Trace levels of metabolites in breathadd another dimension of difficulty because of the quantity of breathneeded to pull out sufficient mass of compound to permit detection isrelatively large.

Current methods for breath collection for subsequent analysis includeexhaling one or two breaths directly into an instrument, or collectingfrom 2 or 3 breaths to many (0.6 to 250 L) into a Tedlar bag—anair-tight bag made of Teflon, plastic, or other inert material. Problemswith these methods, however, limit their usefulness. For example, verylow levels, e.g., less than 1 part per trillion, of metabolites presentin the amount of breath analyzed are not typically sufficient to detect,or are detected with difficulty, by the most sensitive instrumentation.Also, methods for breathing directly into an instrument are cumbersome,inconvenient, and require that the user and instrument be present in thesame location.

For example researchers at Menssana Research have developedBreathscanner 2.5, an instrument that incorporates gas chromatographyand a detector to identify volatiles from the breath of users (e.g.,patients) who breathe directly into an interface with the instrument.This device is cumbersome, and results are dependent upon the amount ofa substance present in breath collected in the short time a user exhalesinto the device. U.S. Pat. No. 5,465,728 describes a hand held devicemeasuring breath components. While portable, this device appears to lacktrace level detection capability. Other methods for measuring breathinclude US Patent Pub. No. 2008/0008666 A1, which describes a method formonitoring the effectiveness of oral malodor treatment by measuring forspecific chemicals listed. It does not appear to allow for novelextraction and detection means. Finally, a major flaw associated withcollecting large quantities of breath with a Tedlar bag is the problemof transferring the metabolite present in a large volume of air into aninstrument while eliminating the dilution effect. This method providesno means for concentrating metabolites. Also with bags, some volatilemetabolites are absorbed into the bag construction materials, or stick(adsorb) to the sides thus unavailable for detection and measurement.

Accordingly, a device is needed to extract low levels (trace levels) ofvolatile, semi-volatile, and non-volatile compounds from breath, for thepurpose of advancing the field of breath metabolomics. Such a devicewould also be useful in dental, food and flavor sciences. For example,in dental science, oral health may be assessed by sampling metabolitespresent in the saliva and breath. Common maladies such as gum health maybe diagnosed based on the presence and concentration of knownmetabolites generated by infection including compounds associated withfoul odor such as carbon disulfide, methyl mercaptan, and dimethylsulfide. In food and flavor sciences, flavor and taste are known aschemosenses, meaning the sense of taste and smell (flavors, tastes andfragrances) are the brain's interpretation of signals generated byinteractions of chemicals (from foods and fragrances) with receptors inthe mouth and nose. By detecting and measuring these chemicals in theoral cavity, improvements in flavor and fragrance technologies,duration, and efficacy may be successfully measured at a level currentlyunavailable. For example how long a product freshens your breath, or howlong a product provides a pleasant taste may be more accurately assessedby measuring the time a breath freshening chemical resides in the oralcavity before being rinsed away in saliva or exhaled in air.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure can be better understood with reference to the followingdrawings. The elements of the drawings are not necessarily to scalerelative to each other, emphasis instead being placed upon clearlyillustrating the principles of the disclosure. Furthermore, likereference numerals designate corresponding parts throughout the severalviews.

FIG. 1 illustrates a chemical extraction apparatus in accordance with anexemplary embodiment of the present disclosure.

FIG. 2 illustrates a top view of the chemical extraction apparatusdepicted by FIG. 1.

FIG. 3 illustrates a back view of the chemical extraction apparatusdepicted by FIG. 1.

FIG. 4 illustrates an exemplary chemical extraction apparatus.

FIG. 5 illustrates the chemical extraction apparatus of FIG. 4 and thefront two teeth of the user.

FIG. 6 illustrates the chemical extraction apparatus of FIG. 4 aftersample elements have been removed from the apparatus.

FIG. 7 illustrates a chemical extraction apparatus in accordance with anexemplary embodiment of the present disclosure.

FIG. 8 illustrates a top view of the chemical extraction apparatusdepicted by FIG. 7.

FIG. 9 illustrates the chemical extraction apparatus of FIG. 7 after theapparatus has been secured to the front teeth of a user.

FIG. 10 illustrates the chemical extraction apparatus of FIG. 8 aftersample elements have been removed from the apparatus.

FIG. 11 illustrates a chemical extraction apparatus in accordance withan exemplary embodiment of the present disclosure.

FIG. 12 illustrates a top view of the chemical extraction apparatusdepicted by FIG. 11.

FIG. 13 illustrates a side view of the chemical extraction apparatusdepicted by FIG. 11.

FIG. 14 illustrates a chemical extraction apparatus in accordance withan exemplary embodiment of the present disclosure.

FIG. 15 illustrates a chemical extraction apparatus in accordance withan exemplary embodiment of the present disclosure.

FIG. 16 illustrates a top view of the chemical extraction apparatusdepicted by FIG. 15.

FIG. 17 illustrates a side view of the chemical extraction apparatusdepicted by FIG. 15.

FIG. 18 illustrates a cross-sectional view of the chemical extractionapparatus depicted by FIG. 17.

FIG. 19 illustrates an exemplary chemical extraction apparatus that isholding a sample element.

FIG. 20 illustrates a sample element and a pair of frames for holdingthe sample element in the chemical extraction apparatus depicted by FIG.19.

FIG. 21 illustrates an end view of the chemical extraction apparatusdepicted by FIG. 19.

FIG. 22 illustrates a side view of the chemical extraction apparatusdepicted by FIG. 19.

FIG. 23 illustrates an exemplary chemical extraction apparatus that isholding a plurality of sample elements.

FIG. 24 illustrates a sample element and a pair of frames for holdingthe sample element in the chemical extraction apparatus depicted by FIG.23.

FIG. 25 illustrates a side view of an exemplary sample element.

FIG. 26 illustrates an end view of the sample element depicted by FIG.25.

FIG. 27 illustrates a side view of an exemplary sample element having afractile geometric shape.

FIG. 28 illustrates an end view of the sample element depicted by FIG.27.

FIG. 29 illustrates an exemplary chemical extraction apparatus that isholding a sample element.

FIG. 30 illustrates an end view of the chemical extraction apparatusdepicted by FIG. 29.

FIG. 31 illustrates an exemplary chemical extraction apparatus that isholding a plurality of sample elements.

FIG. 32 illustrates an end view of the chemical extraction apparatusdepicted by FIG. 31.

FIG. 33 illustrates an exemplary chemical extraction system.

DETAILED DESCRIPTION

The present disclosure generally pertains to apparatuses and methods forextracting volatile, semi-volatile, and non-volatile chemicals from abodily cavity and breath. An apparatus for extracting chemicals in oneexemplary embodiment is portable, convenient, and designed to easily fitin the bodily cavity. It is composed of absorbent material that isintended to remain in the bodily cavity for a period ranging fromminutes to hours, although other time periods are possible. With eachexhalation, air flows over the absorbents, and quantities of chemicalspresent in the breath are absorbed and/or adsorbed. As many (e.g.,thousands) of breaths flow over the absorbent material, chemicalspresent in the breath are retained. Even trace levels of volatilechemicals present in the breath are sufficiently concentrated in theabsorbent material over time to enable detection of these small amountsof chemicals via known analytical techniques. After a period of time,the apparatus is removed from the bodily cavity, and the absorbentmaterial is analyzed by appropriate analytical instrumentation todetermine the chemical compounds absorbed from the breath and bodilycavity (e.g., saliva).

Various types of materials may be used to absorb and/or adsorb chemicalsfrom the breath and bodily cavity. Such materials include, but are notlimited to, polydimethylsiloxane (PDMS), polyvinyl acetate,polyisoprene, styrene-butadiene rubber (SBR), polybutylene,polyacrylate, as well as other polymers that are known in the art, ormay become known in the art, that are safe for use in bodily cavities.Such materials may be used in different ratios in combination with oneanother or alone by themselves. Softening agents such asmicrocrystalline wax may also be utilized to provide a softer, easy tomold polymer. Additional absorbent materials that may be incorporatedinto the device described herein include all forms of activated carbonwith engineered pore sizes such as CarboPack or Carboxen materials,structures known as zeolites, an absorbent material called Tenax, andcyclodextrins.

Note that PDMS alone may be used as the absorbent material. Onecharacteristic of PDMS is that it is hydrophobic. It does not bind waterappreciably, but it does extract other volatile components present in asample matrix (immersed in a liquid or from headspace) by absorptioninto the polymer liquid phase, making it ideal for use in the oral ornasal cavity environment.

Some absorbent material, such as activated carbon, may be hydrophilic.If such material is exposed to saliva for prolonged periods of time, thematerial may absorb significant quantities of water from the salivathereby inhibiting the material's ability to absorb other compounds. Insuch embodiments, the material's contact with saliva may be limited. Forexample, as will be described in more detail hereafter, the absorbentmaterial is positioned in a protection element that helps to reduce thematerial's contact with saliva. However, the protection element has atleast one opening that allows breath to enter the protection element andcontact the absorbent material. The use of the protection element helpsto enhance the absorbent material's ability to absorb and/or adsorbcompounds in the breath.

Moreover, regardless of which type of absorbent material is used, theabsorbent extracts and retains volatile, semi-volatile, and non-volatilecomponents from the breath and bodily cavity by absorption andadsorption. Forces and mechanisms responsible for the absorption and/oradsorption include Van der Waals forces, polarity, and hydrophobicity orhydrophillicity.

After absorption and/or adsorption, chemical components may be desorbed,analyzed, and measured by any of various types of analytical proceduresand instruments. Such methods include, but are not limited to, thermaldesorption and chemical desorption by exposure to solvent as with highperformance liquid chromatography (HPLC). For thermal desorption, theabsorbent is placed in a thermal desorption unit or heated chamber,equipped with inert gas flushing and temperature control. Upon heatingthe chamber, volatiles desorb from the absorbent material, are swept byinert gas (e.g., helium, nitrogen, argon) into a trap mechanism (e.g., aliquid nitrogen cooled cryo-trap, an absorbent material, or acombination thereof). The trap mechanism may be rapidly heated torelease components and deposit them as a tight band on a capillarycolumn for separation by a gas chromatograph (GC) and detection andmeasurement by a detector (e.g., mass spectrometer (MS), flameionization, or flame photometric). Alternatively, the volatiles may bedesorbed by solvent and analyzed by GC as previously described, or byHPLC. HPLC may utilize various detectors, such as MS, infra-red,ultraviolet, diode array, and/or other wavelength of electromagneticradiation.

Data from the analysis may be used in a variety of ways. As an example,it may be determined that the presence of certain chemicals in certainquantities and/or a pattern of certain chemicals over time within thebodily cavity and/or breath may indicate the presence of a certaindisease or condition. Thus, the data may be analyzed to predict ordiagnose whether a user, which could be a human or an animal, has orwill have a certain disease or condition. By keeping the absorbent inthe bodily cavity for an extended period (e.g., several minutes orhours), even trace levels of chemicals can be concentrated in theabsorbent allowing detection of such trace levels by conventionalanalytical equipment.

In one application, the absorbed chemicals are analyzed to determinewhether the user has been exposed to (e.g., inhaled or otherwiseconsumed) certain chemicals. As a mere example, samples from a soldiermay be analyzed to determine whether the soldier has been exposed tochemical weapons and, if so, to identify the type of chemicals to whichhe or she has been exposed. Various other types of conditions may bedetected in other applications.

FIGS. 1-3 depict a chemical extraction apparatus 25 in accordance withan exemplary embodiment of the present disclosure. The apparatus 25comprises a curved support element 27 that helps to support andappropriately position other components of the apparatus 25, as will beseen. The support element 27 has a shape corresponding with the expectedshape of the teeth of a user who is to wear the apparatus 25. In thisregard, the support element 27 is shaped such that it can be positionedalong an outer side of the user's upper teeth. Thus, the support element27 fits between the user's upper teeth and his or her upper lip. Inother embodiments, the support element 27 could be shaped to fit aroundthe user's lower teeth. The support element 27 is sufficiently elasticsuch that it presses against the user's teeth helping to hold theapparatus 25 is place, and it is sufficiently elastic to deform in orderto accommodate various teeth dimensions, which can vary slightly fromuser-to-user.

The apparatus 25 has at least one tab 29 coupled to the support element27. Each tab 29 comprises an arm 33 and a sample element 36, which iscomposed of absorbent material, such as PDMS or other material forabsorbing and/or adsorbing chemicals from the oral cavity and breath. Inone exemplary embodiment, the sample element 36 is composed entirely ofan absorbent material, but other configurations are possible. Indeed, itis possible for only a portion of the sample element 36 to be composedof an absorbent material. For example, the sample element 36 may becomposed of a non-absorbent material and coated with an absorbentmaterial.

Each arm 33 extends from the support element 27 beneath at least onetooth of the user. Further, each arm 33 is coupled to a sample element36 such that the sample element 36 is at a desired position within theoral cavity to enhance its ability for chemical absorption when theapparatus 25 is being worn.

In one exemplary embodiment, each arm 33 is bent or otherwise curvedsuch that the sample element 36 coupled to it contacts the back of theuser's teeth. FIGS. 4 and 5 show one of the sampling elements 36positioned behind a user's front teeth 41. The other teeth of the userare not shown for simplicity. However, for each sample element 36, atleast one tooth is positioned between the sample element 36 and thesupport element 27. In one exemplary embodiment, the arm 33 isdimensioned such that the at least one tooth fits snugly between thesample element 36 and the support element 27 thereby helping to hold theapparatus 25 in place via frictional forces, thereby securing theapparatus 25 to the tooth. However, in other embodiments, the arm 33 forany sample element 36 may be dimensioned such that the sample elements36 barely makes contact with at least one tooth or such that sampleelement 36 is separated from the user's teeth.

While the apparatus 25 is being worn, each sample element 36 absorbsand/or adsorbs chemicals from the user's breath and oral cavity (e.g.,saliva). After exposure for a desired duration, such as several minutesor hours, the apparatus 25 is removed from the oral cavity, and each arm33 is cut by a razor or other sharp instrument to remove the sampleelements 36, as shown by FIG. 6. The removed sample elements 36 can thenbe analyzed to determine the chemicals and the concentrations of thechemicals absorbed and/or adsorbed by the sample elements 36. The datafrom such analysis may then be used for a variety of purposes, such asdiagnosing a disease or condition of the user (e.g., patient) oridentifying a marker or predictor of a disease or condition.

In analytical chemistry, statistical validity is generally considered tobe achieved after three analyses have been performed. Each of the threesample elements 36 can be separately analyzed in order to provide suchstatistical validity. However, it is possible for the apparatus 25 tohave other numbers of sample elements 36 in other embodiments.

In one exemplary embodiment, the sample elements 36 are dimensionedaccording to the size requirements of the analytical equipment that isto be used for analyzing the sample elements 36. For example, manyconventional thermal desorption units are designed to receive sampleshaving a width of up to about 0.08 inches and a length of up to about0.4 inches. To facilitate the use of the sample elements 36 with suchequipment, each sample element 36 preferably has a width less than about0.08 inches and a length less than about 0.4 inches. However, in otherembodiments, other dimensions for the sample elements 36 are possible.Further, the sample elements 36 may be cut or otherwise arranged intoany desired size or shape for analysis.

In addition, as described above, the sample elements 36 are composed ofan absorbent material, such as PDMS. The other components of theapparatus 25 may be composed of the same or other materials. In oneexemplary embodiment, the other components, such as the support element27 and the arms 33, are composed of the same material as the sampleelements 36. If the other components of the apparatus 25 are composed ofan absorbent material, such as PDMS, then such other components may beanalyzed as described above for the sample elements 36. If desired, suchother components may be cut or otherwise arranged into any desired sizeor shape for analysis.

As shown by FIGS. 4 and 5, one of the sample elements 36 is positioneddirectly behind the upper front teeth 41 (referred to as “incisors”) ofthe user. In fact, as described above, such sample element 36 maycontact and possibly press against the inner side of the front teeth 41.Positioning absorbent material behind the front teeth 41 is generallyideal since breath typically flows across the upper palate of the userdirectly toward such location while the user is exhaling. Such alocation may assist in the detection of trace levels of a chemical inthe breath. The other sample elements 36 are positioned behind otherteeth of the user, such as molars, bicuspids or canines.

FIGS. 7 and 8 depict a chemical extraction apparatus 55 in accordancewith an exemplary embodiment of the present disclosure. In the exemplaryembodiment depicted by FIGS. 7 and 8, the apparatus 55 is configuredsuch that multiple sample elements 56 can be positioned directly behindthe front teeth 41.

In this regard, the apparatus 55 has a support element 57 that iscoupled to three sample elements 56 by arms 63. In other embodiments,other numbers of sample elements 56 may be coupled to the supportelement 57. Each of the sample elements 56 is composed of an absorbentmaterial, such as PDSM. In one exemplary embodiment, the sample elements56 are composed entirely of an absorbent material, but otherconfigurations are possible. Indeed, it is possible for only a portionof each sample element 56 to be composed of an absorbent material. Forexample, the sample elements 56 may be composed of a non-absorbentmaterial and coated with an absorbent material.

As shown by FIGS. 7 and 8, the support element 57 is generally circular,but has sufficient elasticity such that it can deform and stretch.Further, the support element 57 is dimensioned such that it can besufficiently stretched, like a rubber band, to extend around at leastone tooth. In one exemplary embodiment, the support element 57 isdimensioned such that it can be sufficiently stretched to extend aroundthe upper front two teeth 41 (referred to as “incisors”) of the user.The inner diameter of the support element 57 is about 0.394 inches priorto stretching and deformation, and the outer diameter of the supportelement 57 is about 0.472 inches prior to stretching and deformation.Further, like the sample elements 36 of FIGS. 1-6, each of the sampleelements 56 for the embodiment shown by FIGS. 7 and 8 has a length lessthan about 0.4 inches and a width less than about 0.08 inches in orderto facilitate analysis of the sample elements 56 for some analyticalequipment. Other dimensions for the support element 57 and the sampleelements 56 are possible in other embodiments. Indeed, in otherembodiments, the support element 57 can be dimensioned to fit aroundother numbers of teeth.

In one exemplary embodiment, the support element 57 is positioned suchthat it snugly fits around the upper front two teeth 41, and the sampleelements are positioned directly behind the front two teeth 41, as shownby FIG. 9. Thus, breath being exhaled should flow toward and contact thesample elements 56. The stretching of the support element 57 induces africtional force that helps to hold the apparatus 55 in place while itis being worn as shown by FIG. 9.

After chemicals in the breath and oral cavity have been absorbed, theapparatus 55 can be removed by sliding the support element 57 down thetooth or teeth around which the support element 57 is wrapped until thesupport element 57 separates from the tooth or teeth. Using a razor orother sharp instrument, the arms 63 are cut to remove the sampleelements 56 from the support element 57. The sample elements 56 can thenbe analyzed by analytical equipment, as described above for the sampleelements 36.

As shown by FIGS. 8-10, the support element 57 has a tab 68 that can begrasped by a user to facilitate positioning and/or removal of thesupport element 57. In this regard, the tab 68 can be pinched betweenthe fingers of the user or other person.

As described above, the sample elements 56 are composed of an absorbentmaterial, such as PDMS. The other components of the apparatus 55 may becomposed of the same or other materials. In one exemplary embodiment,the other components, such as the support element 57 and the arms 63,are composed of the same material as the sample elements 56. If theother components of the apparatus 55 are composed of an absorbentmaterial, such as PDMS, then such other components may be analyzed asdescribed above for the sample elements 56. If desired, such othercomponents may be cut or otherwise arranged into any desired size orshape for analysis.

FIGS. 11-13 depict a chemical extraction apparatus 75 in accordance withan exemplary embodiment of the present disclosure. The apparatus 75 iscomposed of absorbent material. In addition, the apparatus 75 ischewable so that a user can place the apparatus 75 into his or her oralcavity and chew the apparatus, like gum. During chewing, the apparatus75 is deformed, and saliva flow is stimulated. Chemicals present insaliva, oral cavity, and breath are extracted and absorbed into theabsorbent material. After chewing for a desired time period sufficientto extract chemicals from the breath and saliva, the chewed apparatus 75is then removed from the oral cavity and analyzed. If desired, thechewed apparatus 75 may be cut or otherwise re-shaped or arranged in aneffort to facilitate analysis.

In one exemplary embodiment, the chewable apparatus 75 is composed ofdifferent combinations of heat resistant polymers, includingpolydimethylsiloxane (PDMS), polyvinyl acetate, polyisoprene,styrene-butadiene rubber (SBR), and polybutylene. Additionally amicrocrystalline wax may be utilized as a softener. The apparatus 75 isdesigned to be chewed in a manner similar to chewing gum, and variousknown materials typically used in chewing gum may be used to manufacturethe apparatus 75. Further, like other gum products, the apparatus 75 canhave many different sizes and shapes, and the apparatus 75 can bemanufactured using other known techniques for manufacturing chewing gum.

In one exemplary embodiment, PDMS is incorporated into the apparatus 75by placing PDMS and other polymers into a mixer capable of providingsufficient shearing force such as a heated Z-blade mixer. In otherembodiments, other types of absorbent material can be used. Contents areblended for a period (e.g., about 15 to 30 minutes) to provide ahomogenous product and heated to temperatures that range from 50 degreesCelsius (C.) to 200 degrees C. Mixing is conducted until theformulations result in an apparatus 75 that is sufficiently malleablethat it may be chewed by most healthy individuals. Formulations includeconcentrations of PDMS that range from 100% to 0%. Other polymers may beincluded in concentrations that range from 100% to 0%. Edible wax may beadded to increase gum softness. Hydrophobic and hydrophilic nature ofgum can be adjusted by selection and concentration of co-polymerutilized.

Other ingredients which may be added to the gum-like product of thepresent disclosure include other absorbents such as activated carbon,Carbopack, carboxen, edible wax for softening.

FIG. 14 depicts a chemical extraction apparatus 100 in accordance withan exemplary embodiment of the present disclosure. The apparatus 100forms a pacifier that can be used by an infant or other user. Theexemplary apparatus 100 of FIG. 14 has a sample element 102, a handle103, and a support element 105. The handle 103 is in the shape of aring, but other shapes of the handle 103 are possible in otherembodiments. The handle 103 is coupled to the support element 105 andfacilitates grasping of the apparatus 100 by a user. The sample element102 is mounted on the support element 105 and forms a nipple to beinserted into the oral cavity of an infant or other user. The sampleelement 102 is composed of an absorbent material, such as PDMS. In oneexemplary embodiment, the sample element 102 is composed entirely of anabsorbent material, but other configurations are possible. Indeed, it ispossible for only a portion of the sample element 102 to be composed ofan absorbent material. For example, the sample element 102 may becomposed of a non-absorbent material and coated with an absorbentmaterial.

The sample element 102 is inserted through a user's mouth into the oralcavity of a user, similar to a nipple of a conventional pacifier. Whilein the oral cavity, the absorbent material of the sample element 102absorbs and/or adsorbs chemicals from the breath and saliva of the user.After chemicals in the breath and oral cavity have been absorbed for adesired period, such as several minutes or hours, the apparatus 55 isremoved from the user's oral cavity. Using a razor or other sharpinstrument, the sample element 102 is cut to remove the sample element102 or at least a portion of the sample element 102 from the supportelement 57. The removed sample element portion can then be analyzed byanalytical equipment, as described above for the sample elements 36.

It should be noted that there are many different conventional pacifierconfigurations that can be used to implement the apparatus 100. Theembodiment shown by FIG. 14 is exemplary.

FIGS. 15-17 depict an exemplary embodiment of a chemical extractionapparatus 125 in accordance with an exemplary embodiment of the presentdisclosure. The apparatus 125, like the apparatus 100 shown by FIG. 14,forms a pacifier. As shown by FIGS. 15-17, the apparatus 100 has asupport element 127 that is coupled to a hollow protection element 133via an arm 135. The protection element 133 is inserted into the oralcavity of an infant or other user. It is possible for the protectionelement 133 to be composed of absorbent material that can be lateranalyzed similar to the apparatus 100 shown by FIG. 14. However, othermaterials for the protection element 133 are possible.

As shown by FIG. 18, at least one sample element 149 is positionedwithin a cavity 145 of the protection element 133. In one exemplaryembodiment, the apparatus 125 has three sample elements 149 to providestatistical validity, but other numbers of sample elements 149 arepossible in other embodiments. Each sample element 149 is composed of anabsorbent material that extracts chemicals from the user's breath. Inone exemplary embodiment, each sample element 149 is composed entirelyof an absorbent material, but other configurations are possible. Indeed,it is possible for only a portion of each sample element 149 to becomposed of an absorbent material. For example, each sample element 149may be composed of a non-absorbent material and coated with an absorbentmaterial. In addition, each sample element 149 is dimensioned similar tothe sample elements 36 described above for FIGS. 1-6. However, otherdimensions of the sample elements 149 are possible in other embodiments.

In the embodiment shown by FIG. 18, each sample element 149 is coupledto an inner wall of the protection element 133 via a respective arm 152,which may be cut by a razor or other sharp instrument in order toseparate the sample element 149 from the protection element 133. Othertechniques for coupling the sample elements 149 to the protectionelement 133 and/or positioning the sample elements 149 within the cavity145 are possible.

A hole 142 in the protection element 133 allows the user's breath toflow into the cavity 145 and contact the sample elements 149, whichabsorb or adsorb chemicals from the breath while protection element 133is in the oral cavity. However, the protection element 133 helps to keepsaliva from reaching the sample elements 149, although it is possiblefor some saliva to enter the cavity 145 via the hole 142. Limiting theamount of saliva that contacts the sample elements 149 may beparticularly beneficial when the absorbent material of any of the sampleelements 149 is hydrophilic. In this regard, limiting the exposure ofhydrophilic absorbent material to saliva reduces the amount of waterabsorbed by such material thereby enhancing the material's ability toextract chemicals from the user's breath. Note that the hole 142 may belocated at positions other than that shown by FIG. 15, and theprotection element 133 may have any number of holes. The number and sizeof the holes can be selected depending on the degree to which contact ofthe absorbent material with saliva is to be limited.

The protection element 133 is inserted through a user's mouth into theoral cavity of a user, similar to a nipple of a conventional pacifier.While in the oral cavity, the absorbent material of each sample element149 absorbs and/or adsorbs chemicals from the breath of the user. Afterchemicals in the breath have been absorbed for a desired period, such asseveral minutes or hours, the apparatus 125 is removed from the user'soral cavity. Using a razor or other sharp instrument, the protectionelement 149 to provide access to the sample elements 149, which are thenremoved from the cavity 145. In the embodiment shown by FIG. 18, thearms 152 are cut to remove the sample elements 149. However, it ispossible for the sample elements 149 to reside in the cavity 145 withoutbeing coupled to the protection element 133. If desired, the sampleelements 149 may be cut or otherwise rearranged for analysis. Theabsorbent material of the sample elements 149 can be analyzed byanalytical equipment, as described above for the sample elements 36.

In various embodiments described above, absorbent material is positionedwithin the oral cavity of a user for a period of time. Volatile,semi-volatile, and non-volatile chemicals are extracted from the breathand saliva of the user. By keeping the absorbent material in the oralcavity for an extended period of time, such as several minutes or hoursdepending on the types of materials selected, even trace levels of achemical can be concentrated in the absorbent material thereby enablingconventional analytical techniques to detect the chemical.

In one exemplary embodiment, absorbent material (e.g., PDMS) ispositioned within a nasal cavity of a user or within the flow of breathfrom the nasal cavity to absorb and/or adsorb chemicals from the nasalcavity and/or breath flowing through the nasal cavity. There are varioustechniques that could be used to position absorbent material within anasal cavity or the breath flowing through the nasal cavity. Forexample, the absorbent material may be coupled to a nostril attachmentapparatus, such as a clamp, that can be detachably coupled to a nostril.At least one sample element composed of the absorbent material anddimensioned as described above for the sample elements 36 or otherwisemay be coupled to the nostril attachment apparatus. Other configurationsof the absorbent material are possible. After exposure within the nasalcavity or to the breath flowing through the nasal cavity, the sampleelement may be removed from the nostril attachment apparatus andanalyzed, as described above, to determine the concentrations ofchemicals absorbed and/or adsorbed by the sample element. Othertechniques and/or types of devices may be used to position the absorbentmaterial in or close to the nasal cavity.

Positioning the absorbent material to absorb and/or adsorb chemicalsfrom the nasal cavity or breath flowing through the nasal cavity mayhave several advantages. For example, in embodiments in which a chemicalextraction apparatus is positioned within an oral cavity, chemicals fromthe oral cavity, such as tooth or tongue plaque, might interfere to someextent with an analysis to determine the concentration of chemicalsexhaled from the user's lungs. Positioning the absorbent material toabsorb and/or adsorb chemicals from the nasal cavity or breath flowingthrough the nasal cavity would prevent interference by chemicals in theoral cavity.

FIG. 19 depicts a chemical extraction apparatus 215 in accordance withan exemplary embodiment of the present disclosure. The apparatus 215 ofFIG. 19 is adapted for insertion into a nasal cavity of a human, but theapparatus 215 may be adapted for insertion into nasal cavities ofanimals in other embodiments. As an example, the dimensions of theapparatus 215 may be specifically tailored for the size of the nostrilinto which the apparatus 215 is to be inserted.

The exemplary apparatus 215 of FIG. 19 comprises a hollow supportelement 218 that has a tubular shape. In one exemplary embodiment, thesupport element 218 forms a hollow cylinder with constant inner andouter diameters. As an example, the outer diameter is about 1 cm, andthe wall thickness of the support element 218 (i.e., the distance fromthe element's inner surface to its outer surface) is about 1 millimeter(mm). Further, the length of the support element 218 in the x-directionis about 2 cm. In other embodiments, other dimensions are possible. Inaddition, in other embodiments, the support element 218 can be taperedsuch that its inner and outer diameters either decrease or increasealong a length of the support element 218 in the x-direction.

Preferably, the support element 218 is dimensioned to fit snugly into anostril of a user from which chemicals are to be extracted. The supportelement 218 may be inserted into the nostril by hand such that theentire length or a substantial portion of the length of the supportelement 218 is in the user's nostril. The snug fit of the apparatus 215in the nostril holds the apparatus 215 in place while chemicals areabsorbed, and the apparatus 215 may be pulled from the nostril by hand,such as by grasping and pulling the support element 218. Also, it ispossible to apply pressure on an exterior of the nostril at the end ofthe support element 218 that is inserted the furthest into the nostrilin order to force the apparatus 215 out of the nostril. While theapparatus 215 is inserted into the user's nostril, breath may flowthrough the interior region of the support element 218.

FIG. 20 shows the apparatus 215 with the support element 218 removed forillustrative purposes. Referring to FIGS. 19 and 20, the apparatus 215comprises a plurality of frames 221 for holding at least one sampleelement 225. FIG. 21 depicts an end view of the apparatus 215 with thesample element 225 removed for illustrative purposes. In one exemplaryembodiment, the sample element 225 is composed entirely of an absorbentmaterial, such as PDMS, but other configurations of the sample element225 are possible. In the exemplary embodiment shown by FIG. 20, thesample element 225 is in the shape of a solid cylinder, but other shapesare possible. In addition, as will be described below for otherembodiments of the sample element 225, the sample element 225 may behollow, allowing breath to flow through an inner region of the sampleelement 225.

Each frame 221 comprises a plurality of arms 233 that extend from aninner surface of the support element 218 to the sample element 225. Thearms 233 hold the sample element 225 in place while breath flows throughthe frame 218 contacting the sample element 225. In the exemplaryembodiment shown by FIGS. 19-21, there are ten arms 233 in each frame221, but other numbers of the arms 233 are possible in otherembodiments. In one exemplary embodiment, the length of each arm fromthe inner surface of the support element 218 to the sample element 225is about 0.3 centimeters (cm). In the embodiment shown by FIGS. 19-21,each arm 233 forms a rod that is coupled to the sample element 225 atone end and to the inner surface of the support element 218 at the otherend. Further, the region between any arm 233 and an adjacent arm 233 ishollow such that breath may flow between the arms 233. In this regard,the arms 233 form a wire frame 221 that allows breath to pass throughthe frame 221. In other embodiments, other dimensions and configurationsof the arms 233 and other types of frames 221 are possible, and it ispossible for each arm 233 to have any desired cross-sectional shape,such as circular, for example.

Further, it is possible for the support element 218 and arms 233 to becomposed of any desired material. In one exemplary embodiment, theentire apparatus 25 is composed of an absorbent material, such as PDMS,but other materials suitable for insertion into a nasal cavity may beused provided that at least a portion is composed of absorbent material.

FIG. 22 shows a side view of the apparatus 215. The dotted lines 221represent the approximate locations of the two frames 221. In otherembodiments, other numbers of frames 221 are possible. In one exemplaryembodiment, the length of the support element 218 in the x-direction isabout 2 cm, and each frame 221 is positioned about 0.25 cm from arespective end of the support element 218. However, other dimensions arepossible in other embodiments.

FIG. 23 shows an exemplary embodiment of the apparatus 215 in which aplurality of sample elements 225 are held by the apparatus 215 insteadof a single, larger sample element 225, as is shown by FIG. 19. FIG. 24shows the apparatus 215 of FIG. 23 with the support element 218 removedfor illustrative purposes. For each frame 221, a given sample element225 is coupled to a pair of the frame's arms 233. Thus, each sampleelement 225 is coupled to a total of four arms 223 (two arms from eachframe 221). Accordingly, in an embodiment in which each frame 221 hasten arms 233, as shown, five sample elements 225 are mounted to thesupport element 218. In the exemplary embodiment shown by FIG. 23, eachof the sample elements 225 is solid and forms a non-tapered, cylindricalshape, but other types of sample elements 225 and sample element shapesare possible. As an example, hollow sample elements 225 may be used, aswill be described in more detail below. Further, the sample elements 225may be tapered, if desired.

FIGS. 25 and 26 depict an exemplary embodiment of a sample element 225that is hollow and forms a tubular shape. In such an embodiment, breathmay flow through a hollow inner region 241, and chemicals from suchbreath may be absorbed via the inner surface of the sample element 225.Such an embodiment, generally helps to increase the overall surface areathat is exposed to the user's breath relative to an embodiment without ahollow region 241. In one exemplary embodiment, the outer diameter ofthe sample element 225 is about 0.25 mm with a wall thickness of about0.1 mm leaving an inner diameter (i.e., diameter of the hollow region241) of about 0.05 mm. Further, a length of the sample element 225 isabout 1.5 cm allowing the sample element 225 to extend between the twoframes 221 in the exemplary embodiment described above in which theframes 221 are about 1.5 cm apart. Other dimensions of the sampleelement 225 are possible in other embodiments.

However, note that keeping the length of the sample element 225 to about2 cm or less and the width of the sample element 225 to about one-eighth(⅛) of an inch or less may have certain advantages. In particular, manystandard analytical instruments, such as gas chromatograph, areconfigured to accept samples having a maximum length of about 2 cm and amaximum width of about one-eighth (⅛) of an inch. Keeping the dimensionsof the individual sample elements 225 within such size requirementsenables the sample elements 225 to be removed and inserted into suchconventional equipment without having to modify (e.g., cut) the sampleelements 225 thereby facilitating the chemical analysis process.

In the exemplary embodiment shown by FIGS. 25 and 26, the inner andouter surfaces of the sample element 225 are generally smooth. FIGS. 27and 28 show an exemplary embodiment of a sample element 225 having innerand outer surfaces that are not smooth. In this regard, the surfacesexhibit a fractal geometric shape such that the surfaces are rough orjagged. Such a shape generally increases the surface area of theabsorbent material for a given set of element dimensions. For example,in one exemplary embodiment, the dimensions of the sample element 225shown by FIGS. 27 and 28 are the same as those described above for thesample element 225 of FIGS. 25 and 26. However, the surface area ofabsorbent material is greater for the embodiment shown by FIGS. 27 and28 due to the fractal geometric shape of the inner and outer surfaces.

In the embodiment depicted by FIGS. 19-21, the wall of the supportelement 215 is shown to be solid. However, other types of supportelements 215 are possible. As an example, FIG. 29 depicts an exemplaryembodiment in which the support element 218 comprises a plurality ofinterconnected rods 249-251 such that the support element 218 forms awire frame for holding other components of the apparatus 215. FIG. 30shows an end view of the apparatus 215 depicted by FIG. 29.

As shown by FIGS. 29 and 30, the support element 218 has a plurality ofcircular rods 250 that form ends of the support element 218 and that arecoupled to a plurality of straight rods 249. Each of the straight rods249 extends from one of the circular rods 250 to the other circular rod250. Further, there is a pair of circular rods 251, one for each frame221. Each circular rod 251 is coupled to each of the rods 249 and toeach arm 233 of a respective one of the frames 221. Each circular rod251 provides additional mechanical stability at the point of contact forthe arms 233 of a respective one of the frames 221. If desired, othercircular rods (not shown) or other types of devices may be coupled tothe support element 218 to provide additional mechanical support.

FIG. 31 depicts the support element 218 shown by FIG. 29 when aplurality of sample elements 225 are mounted to the support element 218,similar to the sample elements 225 mounted to the support element 218depicted by FIG. 23. In this regard, as in the embodiment depicted byFIG. 23, each support element 225 is coupled to a total of four arms 233but may be coupled to any number of arms 233 in other embodiments. FIG.32 depicts an end view of the apparatus 215 depicted by FIG. 31.

FIG. 33 depicts an exemplary embodiment of a chemical extraction system260 having a pair of chemical extraction apparatuses 215 depicted byFIG. 23. If desired, the chemical extraction apparatuses 215 may bereplaced with any of the embodiments for a chemical extraction apparatus215 described above. As shown by FIG. 33, the chemical extractionapparatuses 215 are coupled to one another via an arm 263 that extendsfrom one of the chemical extraction apparatuses 215 to the other. Duringuse, the system 260 may be positioned such that each chemical extractionapparatus 215 is inserted into a respective nostril of a user. Thus, onechemical extraction apparatus 215 absorbs chemicals from breath passingthrough one nostril, and the other chemical extraction apparatus 215concurrently absorbs chemicals from breath passing through the user'sother nostril. The apparatuses 215 may be pushed into the user'snostrils until the arm 263 contacts the bridge of the user's nosebetween his or her two nostrils. As in the embodiments of chemicalextraction apparatuses for insertion into the oral cavity, any of theembodiments of chemical extraction apparatuses 215 for insertion intothe nasal cavity can be used to absorb chemicals from the user's breath.A single chemical extraction apparatus 215 may be inserted into onenostril, or two chemical extraction apparatuses 215 may be inserted intoboth nostrils. While a chemical extraction apparatus 215 is insertedinto a user's nostril, the sample element 225 absorbs chemicals from theuser's breath that is passing through such nostril. Preferably, thechemical extraction apparatus 215 is secured such that it remains in thepath of breaths from the user for many (e.g., thousands) breaths.

After chemicals in the breath and nasal cavity have been absorbed oradsorbed, the apparatus 215 is pulled from the nasal cavity. Using arazor or other sharp instrument, the arms 233 are cut to remove eachsample element 225 from the other components of the apparatus 215. Eachsample element 225 can then be analyzed via analytical equipment, asdescribed above for the sample elements removed from the oral cavity.Based on such analysis, various conditions can be detected. As anexample, a disease may be diagnosed based on the detection of certainchemicals at certain levels in a sample element 225. In another example,the analysis can reveal whether the user has inhaled or consumed certainchemicals as evidenced by the presence of certain chemicals at certainlevels in a sample element 225. Various types of analysis may beperformed on the sample elements 225 to detect various types ofconditions of interest.

In one exemplary embodiment, the chemical measurements are displayed toa user via a display device (e.g., a monitor, liquid crystal display(LCD), printer) of a computer system. A computer system may be used toautomatically analyze the measurements for predefined signatures ofvarious diseases or conditions. If the measurements match such apredefined signature, information indicative of the match may bedisplayed. Yet other techniques for analyzing or utilizing themeasurement are possible in other embodiments.

In any of the embodiments described above, flavor or scents can be addedto the absorbent material or other portions of the chemical extractionapparatuses. When a chemical extraction apparatus is used in an oralcavity, flavor may be released into the user's oral cavity and tasted bythe user. When a chemical extraction apparatus is used in a nasalcavity, at least one scent may be released into the user's nasal cavityand smelled by the user. The addition of flavor or scent may make theuse of the chemical extraction apparatus more appealing to the userand/or increase the likelihood that the user will utilize the chemicalextraction apparatus for the desired time.

In one exemplary embodiment, absorbent material is included in bones,toys, bridles, or other types of devices typically chewed by animals orotherwise positioned within the oral cavity of animals. For example, abone to be chewed by a dog may include an absorbent material to absorband/or adsorb chemicals from the dog's breath during chewing. Theabsorbent material can be removed after chewing for analysis todetermine the concentrations of chemicals extracted from the dog's oralcavity and/or breath. In another example, absorbent material may beincluded in a portion of a bridle that is inserted into the oral cavityof a horse or other animal. Various other uses of the absorbent materialare possible in other embodiments. If desired, the chewable device, suchas a chewable toy, may be composed entirely of absorbent material,though it is possible for lone a portion of the chewable device to becomposed of absorbent material.

In several embodiments described above, absorbent material is insertedinto the oral or nasal cavity of a user. However, such insertion isunnecessary. For example, the absorbent material may be positionedoutside of a bodily cavity but within the path of breath being exhaledby the user. As a mere example, a system similar to the one shown byFIG. 33 may be secured to the bridge of a user's nose between his or hernostrils and yet position absorbent material in a portion of the supportelement 218 outside of the nasal cavity but within the flow of breathfrom the user.

In one example, absorbent material, such as PDMS, is included in arespirator. As known in the art, a respirator is a device that isinserted into or covers the mouth and/or nose of a user. Somerespirators have a filtering apparatus for filtering air being breathedby a user. Several such respirators are passive in that they do notforce the user to inhale. Some respirators, such as respiratorstypically used in medical applications, force air or gas into the userand allow the user to exhale periodically. Such a respirator may be usedfor a user who is unable to breathe normally. There are many differenttypes of conventional respirators that may be modified to includeabsorbent material, as described herein. Several respirators aredescribed in the following U.S. patents, which are all incorporatedherein by reference: U.S. Pat. Nos. 4,020,834; 4,227,519; 5,678,539;5,423,313; 4,644,947; and 4,596,247.

In one exemplary embodiment, at least one sample element dimensionedlike the sample elements 36 or 225 described above or otherwise isattached to a respirator such that breath from a user flows over theabsorbent material, which absorbs and/or adsorbs chemicals from suchbreath. As an example, the respirator may have a tube that is insertedinto the user's oral cavity, and the respirator may force air or othergas into the user's lungs through the tube. Further, air exhaled by theuser may also pass through such tube. A sample element may be positionedwithin the tube or in-line with the air or other gas passing through thetube. In other embodiments, other configurations of the absorbentmaterial may be used with a respirator to absorb and/or adsorb chemicalsfrom a user's breath.

1-17. (canceled)
 18. A pacifier, comprising: a support element; and anipple for insertion into an oral cavity of a user, the nipple coupledto the support element and having absorbent material for absorbing oradsorbing trace levels of volatile chemicals in breaths of the user. 19.The pacifier of claim 18, further comprising a handle coupled to thesupport element.
 20. The pacifier of claim 18, wherein the nipple has acavity, and wherein the absorbent material is within the cavity.
 21. Thepacifier of claim 20, wherein the nipple has a hole for allowing thebreaths to pass through the hole into the cavity.
 22. The pacifier ofclaim 21, wherein the absorbent material is attached to an inner wall ofthe nipple by an arm extending from the inner wall.
 23. A method,comprising: providing a pacifier having a nipple mounted on a supportelement, wherein the nipple has absorbent material for absorbing oradsorbing trace levels of volatile chemicals in breaths of a user;inserting the nipple, including the absorbent material, of the pacifierinto an oral cavity of the user such that the trace levels of thevolatile chemicals are absorbed or adsorbed into the absorbent material;analyzing the absorbent material with analytical instrumentation;identifying, with the analytical instrumentation, the trace levels ofthe volatile chemicals based on the analyzing; providing an output fromthe analytical instrumentation based on the trace levels identified bythe analytical instrumentation; and diagnosing a condition of the userbased on the output.
 24. The method of claim 23, wherein the nipple hasa cavity, and wherein the absorbent material is within the cavity. 25.The method of claim 24, wherein the nipple has a hole, and wherein thebreaths pass through the hole and into the cavity.
 26. The method ofclaim 25, wherein the absorbent material is attached to an inner wall ofthe nipple by an arm extending from the inner wall, and wherein themethod further comprises removing the absorbent material from the innerwall.
 27. The method of claim 26, wherein the removing comprises cuttingthe arm.
 28. The method of claim 25, further comprising a plurality oftubular sample elements, each of the tubular sample elements having theabsorbent material and attached to an inner wall of the nipple by arespective arm of a plurality of arms extending from the inner wall,wherein the method further comprises removing each of the tubular sampleelements from the inner wall, and wherein the analyzing comprisesanalyzing each of the tubular sample elements.
 29. The method of claim28, wherein the removing comprises cutting each of the plurality ofarms.
 30. The method of claim 23, wherein the analytical instrumentationcomprises a gas chromatograph.
 31. The method of claim 23, wherein theanalytical instrumentation comprises a mass spectrometer.
 32. The methodof claim 23, wherein the absorbent material comprisespolydimethylsiloxane.